- Email: [email protected]
Efficacy of lansoprazole in the treatment of GERD in children
2446
Abstracts
AJG – Vol. 95, No. 9, 2000
Results:
6 1 1 1
cm cm cm cm
Time window
pH threshold
False positive
True positive (symptom index)
Symptom sensitivity index
ROC area
2 min 2 min 15 min 15 min
4.0 4.0 4.0 5.0
0.16 0.23 0.47 0.59
0.25 0.32 0.52 0.66
0.015 0.037 0.096 0.092
0.531 0.527 0.544 0.538
No ROC curve had an area significantly different from 0.5; which indicates that there is neither positive nor negative correlation between acid reflux and symptoms. Conclusions: Regardless of the pH threshold, time window and other parameters that we studied there is a poor relationship between heartburn/ pain symptom and acid reflux. Our data indicate that acid is not the immediate cause of heartburn and non-cardiac chest pain. 120 Assessment of esophageal motility in achalasia using high frequency introluminal ultrasonography (HFIUS) Nonko Pehlivanov, MD, Jinamin Liu, MD, Ravinder K Mittal, MD. San Diego VA Medical Center and University of California, San Diego, CA. Contraction of the esophagus during peristalsis results in thickening of the esophageal muscle in healthy subjects (HS). Patients with nutcracker esophagus and diffuse esophageal spasm show an increase in baseline muscle thickness and an increase in muscle thickness during contraction as well. Aim: To determine the baseline esophageal wall thickness and relationship between intraluminal pressure and muscle thickness during swallow-induced contractions in patients with achalasia (AP) using HFIUS. Methods: Five AP (4 M & 1 F, mean age 62.8 ⫾ 11.2 yrs) and 10 HS (8 M & 2 F, mean age 46.5 ⫾ 13.8 yrs). HFIUS images and esophageal pressures were recorded simultaneously in the lower esophageal sphincter (LES) and at 2, 4, 6, 8 and 10 cm above the LES during resting state and five standardized (5 mL) swallows. The HFIUS images were digitized and the thickness of the muscular layer was measured using image analysis software during the time periods before swallow-induced contraction (baseline) and at the peak of contractions. Results: Baseline muscle layer thickness of LES and the body of the esophagus were significantly thicker in AP compared to HS. In contrast to HS, where there was thickening of the muscle during contractions, AP showed either no change or thinning of the muscle at the peak of pressure waves. At the peak of contraction, HS showed no esophageal lumen. The esophageal lumen size increased at the peak of pressure waves in AP.
HS(b) AP(b) HS(p) AP(p)
LES
2-cm
4-cm
6-cm
8-cm
10-cm
1.91 ⫾ 0.4 2.52 ⫾ 0.6* 2.54 ⫾ 0.3 2.73 ⫾ 0.7
1.25 ⫾ 0.2 1.98 ⫾ 0.5 2.30 ⫾ 0.5 1.95 ⫾ 0.9¶
1.14 ⫾ 0.2 1.78 ⫾ 0.39 2.15 ⫾ 0.5 1.56 ⫾ 0.4¶
1.07 ⫾ 0.1 1.70 ⫾ 0.4* 2.19 ⫾ 0.4 1.66 ⫾ 0.6¶
1.05 ⫾ 0.2 1.62 ⫾ 0.4* 2.15 ⫾ 0.4 1.78 ⫾ 0.6
1.05 ⫾ 0.1 1.47 ⫾ 0.4* 2.03 ⫾ 0.4 1.96 ⫾ 0.9
The symptom of heartburn in achalasia has been attributed to either retention of food in the distal esophagus and production of lactic acid, or gastroesophageal reflux due to transient lower esophageal sphincter relaxation. Aim: To determine if acidification of the esophagus is the cause of the heartburn symptoms in achalasic patients. Methods: Six achalasics (3 M, 3 F; mean age 45.1 ⫾ 6.6 years) with a history of heartburn events on daily basis were investigated with 24-hour esophageal pH monitoring. Manometrical and/or radiological criteria for achalasia were met, and endoscopy ruled out secondary achalasia. Esophageal dilatation was established by radiology studies in all cases. There were no endoscopic signs of esophagitis. Results: Mean percentage of time with esophageal pH ⬍4 during the day, night, and total time was 0.13% (range 0 – 0.3), 0%, and 0.06% (range 0 – 0.2), respectively. Reflux episodes (pH ⬍4) were registered in 3 out of 6 achalasics, mean 0.8 per patient (range 0 –2), and duration up to 2 min. All of them were asymptomatic or connected to eructation. Conversely, none of the 7 heartburn episodes (range 1–2 per person) registered during the study coincided with acidification of the esophagus. Symptom index regarding heartburn was 0% in all cases. Gradual nocturnal pH drop was observed in none of pH tracings. Conclusions: 1. Heartburn when present in classic achalasia patients is not explained by acidification of the esophagus. 2. There are occasional brief reflux episodes, presumably due to lower esophageal sphincter relaxations, but not accompanied by symptoms. Heartburn in the setting of dysphagia for solids and liquids should not deter clinicians from pursuing the diagnosis of achalasia.
122 Efficacy of lansoprazole in the treatment of GERD in children V. Tolia, MD, FACG1, G. Ferry, MD2, T. Gunasekaran, MD3, B. Huang, PhD4, R. Keith, BSN5, L. Book, MD6. 1Children’s Hospital of Michigan, Detroit, MI, 2Texas Children’s Hospital, Houston, TX, 3 Lutheran General Children’s Hospital, Park Ridge, IL, 4Abbott Laboratories, Abbott Park, IL, 5TAP Pharmaceutical Products Inc., Lake Forest, IL, 6Primary Children’s Medical Center, Salt Lake City, UT. Objective: To evaluate the efficacy of lansoprazole (Lan) in the treatment (tx) of GERD in children 1–12 yrs of age. Methods: 66 patients (pts) with GERD symptoms & either erosive (EE, n ⫽ 28) or non-erosive (n ⫽ 38) esophagitis were assigned to tx with Lan based on weight: 15 mg QD if ⱕ30 kg or 30 mg QD if ⬎30 kg (mean dose 0.9 mg/kg). After 2 wks of tx, Lan dose could be titrated up if still symptomatic. Pts were treated for 8 wks; however, pts with EE that were not healed on wk 8 endoscopy continued on tx for an additional 4 wks. Efficacy variables were healing of EE and GERD symptom assessments. Results: Variable
Final Visit
* p⬍0.05 vs. HS (b); ¶ p⬍0.05 vs. HS (p); b— baseline, p—peak pressure.
Healing Rate in Pts with EE (n/N) Overall Symptom Relief: % Better (n/N)
100% (27/27) 76% (47/62) All Lan patients
Conclusions: There is an increase in the baseline muscle thickness in AP, both in the LES and esophagus. Esophageal pressure waves in AP reflect hydrostatic pressure waves rather than true muscle contractions. HFIUS is a powerful tool to study the nature of pressure waves, i.e., true contraction vs. hydrostatic pressure waves in the esophagus.
GERD Symptom(s): % of Days w/GERD Average Score/Day
121 Heartburn in achalasia is not due to esophageal acidification Nonko Pehlivanov M.D., Venko Natzkov M.D.*, Richard McCallum M.D. University of Kansas Medical Center, KS. *Transport Medical Institute, Sofia, Bulgaria.
Baseline 79.8 1.60
Post-Tx 54.6* 0.88*
Symptom score: none ⫽ 0; mild ⫽ 1; moderate ⫽ 2; and severe ⫽ 3. * Statistically significant improvement compared with baseline (p ⬍ 0.001).
All pts with EE at baseline healed after tx with Lan. Over the entire tx period, all pts had significant improvement in % of days with GERD & average GERD score when compared with baseline. 76% of pts reported better overall symptom relief at the final visit. The average final healing/ symptom relief dose was 1.2 mg/kg.
AJG – September, 2000
Abstracts
Conclusions: Lansoprazole was efficacious in healing erosive esophagitis & provided symptom relief in children with GERD. Funded by TAP Pharmaceutical Products Inc.
123 Safety of lansoprazole in the treatment of GERD in children V. Tolia, MD, FACG1, J. Fitzgerald, MD, FACG2, E. Hassall, MD, FACG3, B. Huang, PhD4, B. Pilmer, BSN5, R. Kane III, MD6. 1 Children’s Hospital of Michigan, Detroit, MI, 2Riley Hospital For Children, Indianapolis, IN, 3British Columbia Children’s Hospital, Vancouver, BC, 4Abbott Laboratories, Abbott Park, IL, 5TAP Pharmaceutical Products Inc., Lake Forest, IL, 6Cardinal Glennon Children’s Hospital, St. Louis, MO. Objective: To evaluate the safety of lansoprazole (Lan) in the 8 –12 wk treatment (tx) of GERD in pts 1–12 yrs of age. Methods: 66 pts were assigned to tx with Lan based on weight: 15 mg QD if ⱕ30 kg or 30 mg QD if ⬎30 kg (mean dose 0.9 mg/kg). After 2 wks, Lan could be titrated up if still symptomatic. Safety was assessed by adverse events (AEs), physical exams, vital signs & labs. Results: 9% of 15 mg Lan pts (mean exposure 50.3 days) & 18% of 30 mg Lan pts (mean exposure 49.4 days) reported one or more AE that was considered drug-related prior to increasing dose. Few drug-related AEs were reported after dose increase. Drug-Related AEs* Over Entire Tx Period by Dose at Time of Event Any Event Headache Elevated gastrin Constipation Diarrhea, Vomiting Dizziness, Insomnia
2447
Patients: We evaluated 39 pts, a subset of the GEMS and WAVESS study groups (6 m, 33 f, mean age 38.4 yrs), to further determine possible mechanisms of GES. Methods: We compared: GI Total Symptom Score (TSS), Adrenergic and Cholinergic AFT, electrogastrography (EGG), and Solid Gastric emptying (SGET), at baseline (BL) and 12 months (m) post GES device implantation. Results were compared by descriptive statistics as mean percent change (%␦) and paired t-tests at BL and 12m, and reported as mean ⫾SE. Results: Compared to BL, at 12m we observed: a significant decrease (mean %∆ 38.4 ⫾ 6.3) in Total Symptom Scores (mean TSS 40.5 ⫾ 1.8 at BL vs. 25.4 ⫾ 2.9 at 12m, p ⬍ 0.001); a significant decrease (mean %∆ 20.8 ⫾ 8.6) in Sympathetic Adrenergic Function (SAF) (mean SAF 104.7 ⫾ 5.7 at BL vs. 82.9 ⫾ 8.4, p ⬍ 0.05); an increase (mean %∆ 26.5 ⫾ 14.0) in Vagal Cholinergic Function (mean 21.98 ⫾ 2.3 vs 26.19 ⫾ 3.4, p ⫽ 0.154). A slight decrease (mean %∆ 1.8 ⫾ 5.5) in the ENS measure EGG, (mean EGG 3.8 ⫾ 0.2 vs. 3.6 ⫾ 0.1 cpm, p ⬎ 0.3); and a significant improvement (mean %∆ 19.6 ⫾ 7.0) in SGET % remaining at 120 min (mean SGET 118.7 ⫾ 15.7 at BL vs. 89.83 ⫾ 13.3, p ⬍ 0.05). Conclusions: We conclude that, in this group of patients, long term GES is associated with a symptomatic improvement; accompanied by a marked decrease in SAF, representing possible sympathetic blockade; a moderate increase in VCF, indicating possible cholinergic stimulation; a trend toward normalization of the EGG, indicating a possible ENS effect; and a significant improvement in solid gastric emptying. This data supports the view that the beneficial effects of GES may be associated with modulation of Gastrointestinal Neuro-Enteric function.
Lansoprazole % (n) 15 mg QD (N ⴝ 32)
15 mg BID (N ⴝ 7)
30 mg QD (N ⴝ 37)
45 mg QD (N ⴝ 7)
30 mg BID (N ⴝ 12)
9% (3) 0 3% (1) 6% (2) 0 0
0 0 0 0 0 0
16% (6) 5% (2) 0 3% (1) 5% (2) 5% (2)
0 0 0 0 0 0
8% (1) 0 8% (1) 0 0 0
* All drug-related AEs were mild or moderate in severity.
The AE rates did not suggest a dose-related effect. No pt prematurely discontinued due to an AE & no serious AEs were considered related to Lan. Over the entire tx period, no clinically important trends were observed regardless of dose. Elevations in gastrins were similar to adult studies. Conclusions: Administration of Lan to children 1–12 yrs of age was safe & well tolerated for 8 –12 wks. Funded by TAP Pharmaceutical Products Inc.
STOMACH 124 Long term treatment at gastric electrical stimulation is associated with changes in neuro enteric function Thomas L Abell, Jean Luo*, Hani M Rashed, Paula Eaton, Guy Voller, J Familoni. University of Tennessee-Memphis, Memphis, TN, United States. Purpose: Although Gastric electrical stimulation (GES) appears beneficial in the treatment of chronic nausea and vomiting, exact mechanisms are unknown. Previous work has reported changes in both adrenergic and cholinergic autonomic nervous system function tests (AFT) and enteric (ENS) nervous system measures. (GE 116(4):A1033, 1999.)
125 Endoscopic argon plasma coagulation (APC) for gastric antral vascular ectasias (GAVE) K.W. Adkisson, M.D., S.J. Rogers, M.D., J.P. Cello, M.D. Departments of Medicine and Surgery, San Francisco General Hospital and the University of California, San Francisco. Watermelon stomach or gastric antral vascular ectasia (GAVE) is an infrequent but treatable cause of upper gastrointestinal (UGIB). GAVE is characterized by vascular ectasias along the antral rugae. Treatments proposed include antrectomy, laser photo-coagulation, heater probe/bipolar cautery or injection sclerotherapy. Argon plasma coagulation (APC) is an new endoscopic coagulation modality employing pressurized ionized argon gas delivered via polyethylene catheter to achieve superficial cauterization. Five patients diagnosed with GAVE and anemia underwent treatment with APC at our institution within the past 24 months. One patient was previously treated with YAG laser alone and 1 patient with YAG plus heater probe. During each endoscopic treatment session, endoscopy was performed under conscious sedation followed by ablation of antral ectasias with APC. Routine APC application consisted of multiple, brief pulses from the APC device (ERBE) set at 60 – 65 watts applied by mucosal painting over focal areas of visible ectasias. APC application at these settings resulted in immediate visible mucosal ablation with an egg-white coagulum. Patients received a mean of 7 (range 5–10) treatment sessions (a mean of one session every 65.2 days). Hematocrit (Hct) values immediately preceding APC therapy and packed red blood cell transfusions (PRBC) during a 6 month interval prior to APC were compared to Hct and PRBC requirements during APC therapy. Hct values remained stable or improved while the need for PRBC was either eliminated or substantially decreased in all patients. Statistical significance was not achieved due to the limited sample size. To date, 35 APC procedures have been performed at our institution for GAVE. Patients have tolerated the procedure well with no complications noted. Conclusion: APC is an acceptable endoscopic treatment option for GAVE and may be superior to other forms of coagulation therapy in ablating vascular ectasias.
Abstracts
AJG – Vol. 95, No. 9, 2000
Results:
6 1 1 1
cm cm cm cm
Time window
pH threshold
False positive
True positive (symptom index)
Symptom sensitivity index
ROC area
2 min 2 min 15 min 15 min
4.0 4.0 4.0 5.0
0.16 0.23 0.47 0.59
0.25 0.32 0.52 0.66
0.015 0.037 0.096 0.092
0.531 0.527 0.544 0.538
No ROC curve had an area significantly different from 0.5; which indicates that there is neither positive nor negative correlation between acid reflux and symptoms. Conclusions: Regardless of the pH threshold, time window and other parameters that we studied there is a poor relationship between heartburn/ pain symptom and acid reflux. Our data indicate that acid is not the immediate cause of heartburn and non-cardiac chest pain. 120 Assessment of esophageal motility in achalasia using high frequency introluminal ultrasonography (HFIUS) Nonko Pehlivanov, MD, Jinamin Liu, MD, Ravinder K Mittal, MD. San Diego VA Medical Center and University of California, San Diego, CA. Contraction of the esophagus during peristalsis results in thickening of the esophageal muscle in healthy subjects (HS). Patients with nutcracker esophagus and diffuse esophageal spasm show an increase in baseline muscle thickness and an increase in muscle thickness during contraction as well. Aim: To determine the baseline esophageal wall thickness and relationship between intraluminal pressure and muscle thickness during swallow-induced contractions in patients with achalasia (AP) using HFIUS. Methods: Five AP (4 M & 1 F, mean age 62.8 ⫾ 11.2 yrs) and 10 HS (8 M & 2 F, mean age 46.5 ⫾ 13.8 yrs). HFIUS images and esophageal pressures were recorded simultaneously in the lower esophageal sphincter (LES) and at 2, 4, 6, 8 and 10 cm above the LES during resting state and five standardized (5 mL) swallows. The HFIUS images were digitized and the thickness of the muscular layer was measured using image analysis software during the time periods before swallow-induced contraction (baseline) and at the peak of contractions. Results: Baseline muscle layer thickness of LES and the body of the esophagus were significantly thicker in AP compared to HS. In contrast to HS, where there was thickening of the muscle during contractions, AP showed either no change or thinning of the muscle at the peak of pressure waves. At the peak of contraction, HS showed no esophageal lumen. The esophageal lumen size increased at the peak of pressure waves in AP.
HS(b) AP(b) HS(p) AP(p)
LES
2-cm
4-cm
6-cm
8-cm
10-cm
1.91 ⫾ 0.4 2.52 ⫾ 0.6* 2.54 ⫾ 0.3 2.73 ⫾ 0.7
1.25 ⫾ 0.2 1.98 ⫾ 0.5 2.30 ⫾ 0.5 1.95 ⫾ 0.9¶
1.14 ⫾ 0.2 1.78 ⫾ 0.39 2.15 ⫾ 0.5 1.56 ⫾ 0.4¶
1.07 ⫾ 0.1 1.70 ⫾ 0.4* 2.19 ⫾ 0.4 1.66 ⫾ 0.6¶
1.05 ⫾ 0.2 1.62 ⫾ 0.4* 2.15 ⫾ 0.4 1.78 ⫾ 0.6
1.05 ⫾ 0.1 1.47 ⫾ 0.4* 2.03 ⫾ 0.4 1.96 ⫾ 0.9
The symptom of heartburn in achalasia has been attributed to either retention of food in the distal esophagus and production of lactic acid, or gastroesophageal reflux due to transient lower esophageal sphincter relaxation. Aim: To determine if acidification of the esophagus is the cause of the heartburn symptoms in achalasic patients. Methods: Six achalasics (3 M, 3 F; mean age 45.1 ⫾ 6.6 years) with a history of heartburn events on daily basis were investigated with 24-hour esophageal pH monitoring. Manometrical and/or radiological criteria for achalasia were met, and endoscopy ruled out secondary achalasia. Esophageal dilatation was established by radiology studies in all cases. There were no endoscopic signs of esophagitis. Results: Mean percentage of time with esophageal pH ⬍4 during the day, night, and total time was 0.13% (range 0 – 0.3), 0%, and 0.06% (range 0 – 0.2), respectively. Reflux episodes (pH ⬍4) were registered in 3 out of 6 achalasics, mean 0.8 per patient (range 0 –2), and duration up to 2 min. All of them were asymptomatic or connected to eructation. Conversely, none of the 7 heartburn episodes (range 1–2 per person) registered during the study coincided with acidification of the esophagus. Symptom index regarding heartburn was 0% in all cases. Gradual nocturnal pH drop was observed in none of pH tracings. Conclusions: 1. Heartburn when present in classic achalasia patients is not explained by acidification of the esophagus. 2. There are occasional brief reflux episodes, presumably due to lower esophageal sphincter relaxations, but not accompanied by symptoms. Heartburn in the setting of dysphagia for solids and liquids should not deter clinicians from pursuing the diagnosis of achalasia.
122 Efficacy of lansoprazole in the treatment of GERD in children V. Tolia, MD, FACG1, G. Ferry, MD2, T. Gunasekaran, MD3, B. Huang, PhD4, R. Keith, BSN5, L. Book, MD6. 1Children’s Hospital of Michigan, Detroit, MI, 2Texas Children’s Hospital, Houston, TX, 3 Lutheran General Children’s Hospital, Park Ridge, IL, 4Abbott Laboratories, Abbott Park, IL, 5TAP Pharmaceutical Products Inc., Lake Forest, IL, 6Primary Children’s Medical Center, Salt Lake City, UT. Objective: To evaluate the efficacy of lansoprazole (Lan) in the treatment (tx) of GERD in children 1–12 yrs of age. Methods: 66 patients (pts) with GERD symptoms & either erosive (EE, n ⫽ 28) or non-erosive (n ⫽ 38) esophagitis were assigned to tx with Lan based on weight: 15 mg QD if ⱕ30 kg or 30 mg QD if ⬎30 kg (mean dose 0.9 mg/kg). After 2 wks of tx, Lan dose could be titrated up if still symptomatic. Pts were treated for 8 wks; however, pts with EE that were not healed on wk 8 endoscopy continued on tx for an additional 4 wks. Efficacy variables were healing of EE and GERD symptom assessments. Results: Variable
Final Visit
* p⬍0.05 vs. HS (b); ¶ p⬍0.05 vs. HS (p); b— baseline, p—peak pressure.
Healing Rate in Pts with EE (n/N) Overall Symptom Relief: % Better (n/N)
100% (27/27) 76% (47/62) All Lan patients
Conclusions: There is an increase in the baseline muscle thickness in AP, both in the LES and esophagus. Esophageal pressure waves in AP reflect hydrostatic pressure waves rather than true muscle contractions. HFIUS is a powerful tool to study the nature of pressure waves, i.e., true contraction vs. hydrostatic pressure waves in the esophagus.
GERD Symptom(s): % of Days w/GERD Average Score/Day
121 Heartburn in achalasia is not due to esophageal acidification Nonko Pehlivanov M.D., Venko Natzkov M.D.*, Richard McCallum M.D. University of Kansas Medical Center, KS. *Transport Medical Institute, Sofia, Bulgaria.
Baseline 79.8 1.60
Post-Tx 54.6* 0.88*
Symptom score: none ⫽ 0; mild ⫽ 1; moderate ⫽ 2; and severe ⫽ 3. * Statistically significant improvement compared with baseline (p ⬍ 0.001).
All pts with EE at baseline healed after tx with Lan. Over the entire tx period, all pts had significant improvement in % of days with GERD & average GERD score when compared with baseline. 76% of pts reported better overall symptom relief at the final visit. The average final healing/ symptom relief dose was 1.2 mg/kg.
AJG – September, 2000
Abstracts
Conclusions: Lansoprazole was efficacious in healing erosive esophagitis & provided symptom relief in children with GERD. Funded by TAP Pharmaceutical Products Inc.
123 Safety of lansoprazole in the treatment of GERD in children V. Tolia, MD, FACG1, J. Fitzgerald, MD, FACG2, E. Hassall, MD, FACG3, B. Huang, PhD4, B. Pilmer, BSN5, R. Kane III, MD6. 1 Children’s Hospital of Michigan, Detroit, MI, 2Riley Hospital For Children, Indianapolis, IN, 3British Columbia Children’s Hospital, Vancouver, BC, 4Abbott Laboratories, Abbott Park, IL, 5TAP Pharmaceutical Products Inc., Lake Forest, IL, 6Cardinal Glennon Children’s Hospital, St. Louis, MO. Objective: To evaluate the safety of lansoprazole (Lan) in the 8 –12 wk treatment (tx) of GERD in pts 1–12 yrs of age. Methods: 66 pts were assigned to tx with Lan based on weight: 15 mg QD if ⱕ30 kg or 30 mg QD if ⬎30 kg (mean dose 0.9 mg/kg). After 2 wks, Lan could be titrated up if still symptomatic. Safety was assessed by adverse events (AEs), physical exams, vital signs & labs. Results: 9% of 15 mg Lan pts (mean exposure 50.3 days) & 18% of 30 mg Lan pts (mean exposure 49.4 days) reported one or more AE that was considered drug-related prior to increasing dose. Few drug-related AEs were reported after dose increase. Drug-Related AEs* Over Entire Tx Period by Dose at Time of Event Any Event Headache Elevated gastrin Constipation Diarrhea, Vomiting Dizziness, Insomnia
2447
Patients: We evaluated 39 pts, a subset of the GEMS and WAVESS study groups (6 m, 33 f, mean age 38.4 yrs), to further determine possible mechanisms of GES. Methods: We compared: GI Total Symptom Score (TSS), Adrenergic and Cholinergic AFT, electrogastrography (EGG), and Solid Gastric emptying (SGET), at baseline (BL) and 12 months (m) post GES device implantation. Results were compared by descriptive statistics as mean percent change (%␦) and paired t-tests at BL and 12m, and reported as mean ⫾SE. Results: Compared to BL, at 12m we observed: a significant decrease (mean %∆ 38.4 ⫾ 6.3) in Total Symptom Scores (mean TSS 40.5 ⫾ 1.8 at BL vs. 25.4 ⫾ 2.9 at 12m, p ⬍ 0.001); a significant decrease (mean %∆ 20.8 ⫾ 8.6) in Sympathetic Adrenergic Function (SAF) (mean SAF 104.7 ⫾ 5.7 at BL vs. 82.9 ⫾ 8.4, p ⬍ 0.05); an increase (mean %∆ 26.5 ⫾ 14.0) in Vagal Cholinergic Function (mean 21.98 ⫾ 2.3 vs 26.19 ⫾ 3.4, p ⫽ 0.154). A slight decrease (mean %∆ 1.8 ⫾ 5.5) in the ENS measure EGG, (mean EGG 3.8 ⫾ 0.2 vs. 3.6 ⫾ 0.1 cpm, p ⬎ 0.3); and a significant improvement (mean %∆ 19.6 ⫾ 7.0) in SGET % remaining at 120 min (mean SGET 118.7 ⫾ 15.7 at BL vs. 89.83 ⫾ 13.3, p ⬍ 0.05). Conclusions: We conclude that, in this group of patients, long term GES is associated with a symptomatic improvement; accompanied by a marked decrease in SAF, representing possible sympathetic blockade; a moderate increase in VCF, indicating possible cholinergic stimulation; a trend toward normalization of the EGG, indicating a possible ENS effect; and a significant improvement in solid gastric emptying. This data supports the view that the beneficial effects of GES may be associated with modulation of Gastrointestinal Neuro-Enteric function.
Lansoprazole % (n) 15 mg QD (N ⴝ 32)
15 mg BID (N ⴝ 7)
30 mg QD (N ⴝ 37)
45 mg QD (N ⴝ 7)
30 mg BID (N ⴝ 12)
9% (3) 0 3% (1) 6% (2) 0 0
0 0 0 0 0 0
16% (6) 5% (2) 0 3% (1) 5% (2) 5% (2)
0 0 0 0 0 0
8% (1) 0 8% (1) 0 0 0
* All drug-related AEs were mild or moderate in severity.
The AE rates did not suggest a dose-related effect. No pt prematurely discontinued due to an AE & no serious AEs were considered related to Lan. Over the entire tx period, no clinically important trends were observed regardless of dose. Elevations in gastrins were similar to adult studies. Conclusions: Administration of Lan to children 1–12 yrs of age was safe & well tolerated for 8 –12 wks. Funded by TAP Pharmaceutical Products Inc.
STOMACH 124 Long term treatment at gastric electrical stimulation is associated with changes in neuro enteric function Thomas L Abell, Jean Luo*, Hani M Rashed, Paula Eaton, Guy Voller, J Familoni. University of Tennessee-Memphis, Memphis, TN, United States. Purpose: Although Gastric electrical stimulation (GES) appears beneficial in the treatment of chronic nausea and vomiting, exact mechanisms are unknown. Previous work has reported changes in both adrenergic and cholinergic autonomic nervous system function tests (AFT) and enteric (ENS) nervous system measures. (GE 116(4):A1033, 1999.)
125 Endoscopic argon plasma coagulation (APC) for gastric antral vascular ectasias (GAVE) K.W. Adkisson, M.D., S.J. Rogers, M.D., J.P. Cello, M.D. Departments of Medicine and Surgery, San Francisco General Hospital and the University of California, San Francisco. Watermelon stomach or gastric antral vascular ectasia (GAVE) is an infrequent but treatable cause of upper gastrointestinal (UGIB). GAVE is characterized by vascular ectasias along the antral rugae. Treatments proposed include antrectomy, laser photo-coagulation, heater probe/bipolar cautery or injection sclerotherapy. Argon plasma coagulation (APC) is an new endoscopic coagulation modality employing pressurized ionized argon gas delivered via polyethylene catheter to achieve superficial cauterization. Five patients diagnosed with GAVE and anemia underwent treatment with APC at our institution within the past 24 months. One patient was previously treated with YAG laser alone and 1 patient with YAG plus heater probe. During each endoscopic treatment session, endoscopy was performed under conscious sedation followed by ablation of antral ectasias with APC. Routine APC application consisted of multiple, brief pulses from the APC device (ERBE) set at 60 – 65 watts applied by mucosal painting over focal areas of visible ectasias. APC application at these settings resulted in immediate visible mucosal ablation with an egg-white coagulum. Patients received a mean of 7 (range 5–10) treatment sessions (a mean of one session every 65.2 days). Hematocrit (Hct) values immediately preceding APC therapy and packed red blood cell transfusions (PRBC) during a 6 month interval prior to APC were compared to Hct and PRBC requirements during APC therapy. Hct values remained stable or improved while the need for PRBC was either eliminated or substantially decreased in all patients. Statistical significance was not achieved due to the limited sample size. To date, 35 APC procedures have been performed at our institution for GAVE. Patients have tolerated the procedure well with no complications noted. Conclusion: APC is an acceptable endoscopic treatment option for GAVE and may be superior to other forms of coagulation therapy in ablating vascular ectasias.